# K072822: Funhaler, Model V-201E

- Pathway: 510(k) (Traditional)
- Applicant: Infamed, Ltd.
- Decided: Nov 26, 2007 after 55 days
- Product code: CAF (Nebulizer (Direct Patient Interface))
- Device class: 2
- Regulation: 21 CFR 868.5630
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 2 generations back to K962822 (1996). 2 ancestors in all.
No later device cites it as a predicate yet.
0 of 3 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K042546: Funhaler, Model FH 101, Infamed, Ltd. (2005) Summary page 1.

## Indications for use
Funhaler is intended for use primarily in the pediatric population. Funhaler is used in combination with a Metered Dose Inhaler for respiratory drug delivery.

Source page: https://510kreport.com/device/K072822
Methodology: https://510kreport.com/methodology